Introduction
The pharmaceutical market, particularly for controlled substances like oxycodone and acetaminophen, is complex and influenced by various factors including regulatory policies, market demand, and global pricing trends. This analysis focuses on the market dynamics and price projections for the specific NDC 42858-0102, which corresponds to Oxycodone and Acetaminophen Tablets, USP, 5 mg/325 mg, manufactured by Rhodes Pharmaceuticals L.P.
Market Context
Global Pricing Trends
The prices of prescription drugs in the U.S. are significantly higher compared to other countries. According to an ASPE issue brief, by 2022, the average price per unit in the U.S. was 5.5 times as high as in the OECD (excluding the U.S.) and 7.7 times as high as the rest of the world (excluding the U.S.)[3].
U.S. Market Specifics
In the U.S., the prescription drug market has seen significant growth in sales revenues, largely driven by price increases rather than volume growth. Between 2017 and 2022, the U.S. saw an average price increase of 14% for prescription drugs, contrasting with decreases in the world and OECD (excluding the U.S.)[3].
Pricing Components and Rebates
Wholesale Acquisition Cost (WAC)
The Wholesale Acquisition Cost (WAC) is a critical component in determining the pricing of prescription drugs. For NDC 42858-0102, the WAC plus 20% is listed as $12.00 per 100 tablets, or $0.12 per pill[5].
Rebates and Discounts
Rebates and discounts play a significant role in the final cost of prescription drugs. Data from the Maine Health Data Organization (MHDO) shows that rebates can significantly reduce the cost for payers, but pharmacies may still receive higher income due to these rebates. For example, some pharmacies receive greater income for a product than the product’s manufacturer due to rebate structures[2].
Regulatory Environment
DEA Schedule and Marketing Status
Oxycodone and Acetaminophen Tablets, USP, are classified as a Schedule II controlled substance due to their potential for abuse. This classification affects their distribution, prescribing, and pricing. The drug is marketed under an Abbreviated New Drug Application (ANDA), which allows for generic versions to enter the market, potentially influencing pricing dynamics[4].
Price Projections
Historical Price Trends
Historical data indicates that the prices of generic drugs, including oxycodone and acetaminophen combinations, have generally decreased or remained stable. However, brand-name drugs have seen price increases. For instance, in 2021, the WAC for generic drugs decreased in most categories, while brand-name drugs saw increases[2].
Future Pricing
Given the current trends, it is likely that the prices for NDC 42858-0102 will remain relatively stable or see minor decreases due to competitive pressures from other generic manufacturers. However, any significant changes in regulatory policies, market demand, or the introduction of new formulations could impact pricing.
Impact of Global Market Trends
The U.S. market is unique in its pricing dynamics, but global trends can influence domestic prices. If there is a shift towards more uniform global pricing or increased international competition, it could potentially drive down prices in the U.S. market.
Key Factors Influencing Pricing
Demand and Supply
Changes in demand due to public health policies or shifts in medical practices can impact pricing. For example, efforts to reduce opioid prescriptions could decrease demand and subsequently affect prices.
Regulatory Changes
Any changes in DEA scheduling, FDA regulations, or state-level transparency laws can significantly impact the pricing and availability of controlled substances.
Competitive Landscape
The presence of multiple generic manufacturers for oxycodone and acetaminophen combinations keeps prices competitive. New entrants into the market or consolidation among existing players could alter the pricing landscape.
Conclusion
The pricing of Oxycodone and Acetaminophen Tablets, USP (NDC 42858-0102), is influenced by a complex interplay of global pricing trends, regulatory environments, and market dynamics. While historical trends suggest stable or decreasing prices for generic versions, future projections must consider potential regulatory changes, shifts in demand, and the competitive landscape.
Key Takeaways
- Global Pricing Disparities: U.S. prices are significantly higher than global averages.
- WAC and Rebates: Wholesale Acquisition Costs plus rebates play a crucial role in final pricing.
- Regulatory Impact: DEA scheduling and FDA regulations significantly influence pricing and availability.
- Market Dynamics: Competitive pressures from generic manufacturers and changes in demand can affect prices.
- Future Projections: Prices are likely to remain stable or decrease slightly due to competitive and regulatory factors.
FAQs
What is the current WAC for NDC 42858-0102?
The current WAC plus 20% for NDC 42858-0102 is $12.00 per 100 tablets, or $0.12 per pill[5].
How do rebates affect the pricing of prescription drugs?
Rebates can significantly reduce the cost for payers, but may result in higher income for pharmacies due to the rebate structures[2].
What is the DEA schedule for Oxycodone and Acetaminophen Tablets?
Oxycodone and Acetaminophen Tablets are classified as a Schedule II controlled substance[4].
How do global pricing trends impact U.S. drug prices?
Global pricing trends can influence U.S. prices, especially if there is a move towards more uniform global pricing or increased international competition[3].
What factors influence the pricing of NDC 42858-0102?
Key factors include demand and supply dynamics, regulatory changes, and the competitive landscape among generic manufacturers.
Sources
- DailyMed: Oxycodone Hydrochloride tablet - DailyMed
- MHDO Rx Transparency Report: MHDO Rx Transparency Report_221213.pdf
- ASPE Issue Brief: International Market Size and Prices
- DailyMed: Oxycodone and Acetaminophen tablet - DailyMed
- Pfizer: Information for Vermont Prescribers of Prescription Drugs - Pfizer
